Polyphor AG / Key word(s): Study
Allschwil, Switzerland, October 29, 2020
Polyphor completes recruitment in Phase III trial of balixafortide in metastatic breast cancer
Polyphor AG (SIX: POLN) today announces that it has completed recruitment in its FORTRESS Phase III study of balixafortide in metastatic breast cancer. A total of 411 patients have been recruited, including 323 in the third line cohort and 88 patients in the second line cohort. Although recruitment is closed, Polyphor will allow all patients that have already registered for the study to be enrolled. This may increase the final number of patients enrolled in the study to approximately 430. As previously communicated, data on the key primary endpoint of FORTRESS, progression free survival (PFS) in the overall population, is planned for Q4 2021. An analysis of the objective response rate (ORR) in eligible patients in third and later lines of chemotherapy is planned for Q2 2021.
"We are pleased to have completed recruitment in this important study in a timely manner. Balixafortide is currently the only potent blocker of CXCR4, a key molecule involved in tumor growth and metastasis, in Phase 3 clinical development for a solid tumor and as such, it has significant potential to improve the lives of patients," said Dr. Frank Weber, Chief Medical and Development Officer at Polyphor. "We would like to take this opportunity to thank first and foremost the patients, but also the investigators and the local staff as well as our employees for their active participation in this study. This great effort has enabled us to complete the recruitment as planned, despite the difficulties caused by the current pandemic."
The FORTRESS study (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial which investigates the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, locally recurrent or metastatic breast cancer.
Subject to the data, Polyphor may submit a filing for accelerated approval in the US based on the analysis of the ORR, confirmed by an independent blinded review, and of the associated durability of response. The full approval would be based on the magnitude of PFS on blinded independent review, supported by an overall survival trend favoring the balixafortide arm and a favorable risk-benefit profile.
For more information about the POL6326-009 clinical trial of balixafortide, please visit www.clinicaltrials.gov (Identifier: NCT03786094)
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